April 23, 2001

Dr. Robert McGuire
Associate Administrator for Hazardous Materials Safety
Dockets Management System
U.S. Department of Transportation
Room PL 401
400 Seventh St., SW
Washington, DC 20590-0001

Re: DOT Docket No. RSPA 98-3971 (HM-226); "Hazardous Materials: Revision to Standards for Infectious Substances and Genetically Modified Micro-organisms" (Notice of proposed rulemaking published January 22, 2001)

Dear Dr. McGuire:

The Hazardous Materials Advisory Council (HMAC) appreciates the opportunity to comment on the Notice of Proposed Rulemaking concerning "Hazardous Materials: Revision to Standards for Infectious Substances and Genetically Modified Micro-Organisms" published in the Federal Register on January 22, 2001.

HMAC is an international, non-profit, educational organization devoted to promoting safety in the domestic and international transportation and handling of hazardous materials, substances and wastes. HMAC represents shippers, carriers of all modes, container manufacturers and reconditioners, emergency response and waste clean-up companies, and a variety of other companies and trade associations involved in the field of hazardous materials transportation.

HMAC has been a long-standing supporter of consistency in hazardous materials programs as we strongly feel that this increases safety by reducing complexity, simplifying training and enhancing the understanding of regulatory compliance.

HMAC comments focus on the following areas: scope of the rulemaking, terms and definitions, harmonization with international transportation regulations, consistency with other federal agencies, and proposed regulatory text.

Scope of the NPRM

The NPRM proposes to adopt the World Health Organization's Risk Group criteria as the new classification criteria for substances regulated within Division 6.2, thereby aligning the HMR with the United Nations Recommendations on the Transport of Dangerous Goods and the International Civil Aviation Organization's Technical Instructions for the Safe Transport of Dangerous Goods by Air. HMAC understands that the WHO Risk Groups were intended to address laboratory conditions and they are not easily adaptable to transportation; however, HMAC supports the inclusion of the WHO Risk Group criteria into the HMR for consistency and harmonization with existing international regulations. We note that the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods plans to examine classification criteria for Division 6.2, which might provide an alternative to the WHO Risk Groups. We would expect that RSPA will address the outcome of those deliberations in a future rulemaking.

Relative to the current exception for diagnostic specimens, biological products, etc., from the requirements of the HMR, HMAC supports the elimination of that exception. It is our belief that the current exception, while broadly useful to the shipping community, was not scientifically based and often contributed to confusion of those attempting to comply with the HMR.

The NPRM further proposes to apply the "materials of trade" (MOT) exception to a material which is a diagnostic specimen, biological product or regulated medical waste, when carried by private motor carriers. This exception would impose minimum packaging and hazard communication requirements, while limiting the maximum gross weight of MOT that may be carried on a motor vehicle. Elsewhere in the NPRM, RSPA proposes ".a complete exception from the HMR for diagnostic specimens transported by private or contract motor carriers". HMAC would note that these two proposed provisions seem to be inconsistent with each other relative to the risk posed by a diagnostic specimen transported in a motor vehicle. If diagnostic specimens are completely exempted from the HMR when transported as noted above, when would a shipper need the MOT exception?

Throughout the NPRM, RSPA appears to use the term "Division 6.2" in two separate contexts. First it appears to describe all materials (i.e., infectious substances, diagnostic specimens, biological products, regulated medical waste, genetically modified micro-organisms, etc.) which are addressed within the classification of Division 6.2. However, there is also text within the NPRM that appears to use the term "Division 6.2" interchangeably with the term "infectious substance". HMAC will address this issue further below in these comments.

The NPRM seems to make an exception to the training requirements of Subpart H (sections 172.700-.704) in the text of the proposed new section 173.199 which states in 173.199(a) "Diagnostic specimens are excepted from other requirements of this subchapter when offered for transportation or transported in accordance with this section" and in section 173.199(d) "Used health care products being returned to the manufacturer are excepted from the requirements of this subchapter when offered for transportation or transported in accordance with this section." RSPA then addresses training for persons who offer or transport a diagnostic specimen or a used health care product in section 173.199(e) of the NPRM; however, the language is very vague in stating ".must be informed of the requirements of this section". HMAC encourages RSPA to offer additional text relative to what would constitute compliance with "must be informed".

HMAC is concerned that "used health care products" as defined in the NPRM will encompass far more articles than is warranted by any perceived safety risk associated with their transport. Many devices and equipment, which would appear to be subject to the proposed definition, are too large to be packaged in the manner outlined in the newly proposed section 173.199(d)(1)-(3). Further, when considering materials being transported by motor carrier, HMAC believes there is an inconsistency between the proposed treatment of body fluids which meet the definition of a diagnostic specimen, while containing pathogens of Risk Groups 2 and 3, and the same body fluids trapped in a piece of equipment. With some exclusions, such as a used health care product that is capable of cutting or penetrating skin or packaging material, HMAC believes there is logic in specifying that a used health care product contaminated with a material that would otherwise meet the definition of a diagnostic specimen, should have the same complete exception from the HMR afforded to a diagnostic specimen, when either is transported by a motor carrier.

Terms and Definitions

HMAC agrees with RSPA's efforts to revise the various definitions for materials which fall within the classification of Division 6.2. However, HMAC would like to draw attention to the following terms and definitions which we believe are unclear in the NPRM.

Section 173.134(a)(1) Division 6.2 (infectious substance). In this text the NPRM strongly suggests that the terms "Division 6.2" and "infectious substances" are interchangeable terms, however, Division 6.2 is a class of materials and not an entry in the Hazardous Materials Table. We believe this will add to confusion about selection of a Proper Shipping Name. Hopefully, our comments, which follow, will assist in explaining our concern.

Section 173.134(a)(2)(ii) Biological product. The definition of biological product states: "Biological products known to contain or suspected of containing a pathogen in Risk Group 2, 3, or 4 must be classed as Division 6.2 and described under UN 2814 or UN 2900, as appropriate, unless otherwise excepted". This text would seem to suggest that a person who wishes to ship a biological product containing a Risk Group 3 pathogen, and for which there is no applicable exception, would need to identify the shipment as "Biological product, 6.2, UN 2814". As this option does not appear to be a valid one, HMAC proposes the text in this definition be amended to read: "Biological products known to contain or suspected of containing a pathogen in Risk Group 2, 3, or 4 must be classed as in Division 6.2 as infectious substance and described under UN 2814 or UN 2900, as appropriate, unless otherwise excepted."

Section 173.134(a)(4) Diagnostic specimen. Similarly, HMAC proposes that RSPA amend the text in this definition as follows: "...from a Risk Group 4 micro-organism pathogen, in which case it must be identified as an infectious substance and assigned to UN 2814 or UN 2900, as appropriate."

Section 173.134(a)(5) Regulated medical waste. Again, for reasons sited above, HMAC proposes the text in this definition be amended to read: "Regulated medical waste containing an infectious substance in Risk Group 4 must be classed as in Division 6.2 as infectious substance and described under UN 2814 or UN 2900, as appropriate."

HMAC questions why the definition of "Used health care products" is not included in section 173.134 with the other Division 6.2 definitions. Moving the definition to 173.134 would not appear to negatively impact the provisions proposed in the new section 173.199(d), which would then read: "(d) Used health care products. Used health care products being returned to the manufacturer are excepted from..."

If this change is adopted, a new paragraph "(9)" under 173.134(a) "Definitions and classification criteria" is needed. Our suggested text is: "(9) Used health care products. Used health care products are medical, diagnostic, or research devices and equipment, and personal care products used by consumers, medical professionals, or pharmaceutical providers that may be contaminated with an infectious substance but do not meet the definition of a diagnostic specimen, biological product, or regulated medical waste."

Harmonization with International Transportation Regulations

Infectious substance label. Section 172.432 prescribes the requirements for the label, which includes text regarding notification of CDC and the CDC phone number. As this information would be unique to labels created for transport in the U.S., will RSPA accept packages labeled with an internationally acceptable label as being in compliance with the HMR?

Classification of diagnostic specimen. While the definition of diagnostic specimen proposed in section 173.134(a)(4) appears to be essentially the same as that which was recently adopted by the UNCETDG for the 12th Edition of the UN Model Regulations, it is not consistent with the definition presently in use in the ICAO Technical Instructions. Where the NPRM proposes any sample other than one containing Risk Group 4 pathogens could meet the definition of a diagnostic specimen, the ICAO TI clearly states that samples ".known or reasonably expected to contain pathogens in risk groups 2, 3 or 4.must be classified in Division 6.2 under UN 2814 or UN 2900, as appropriate". The end result would be that a sample containing a Risk Group 3 pathogen would have a complete exception from the HMR when transported by private or contract motor carrier and be subject to regulation as infectious substance, labeled 6.2 and fully packaged and documented when intended to be transported by air.

Consistency With Other Agency's Regulations

As noted in the NPRM, multiple federal agencies currently assert jurisdiction over the shipment of infectious substances and genetically modified micro-organisms. Until a comprehensive set of regulations exist, shippers will continue to be led in conflicting directions as agencies exercise their independent jurisdiction. Comprehensive regulations should allow agencies the option of deferring to those regulations rather than exercising potentially confusing independent jurisdiction. As U.S. DOT is the government agency that has the responsibility to coordinate, to the extent possible, shipping requirements of the U.S. with other countries and international modal bodies through the UNCETDG, ICAO and the IMO, HMAC applauds RSPA's efforts in this regard.

Proposed Regulatory Text

Section 172.102 Special Provisions. Amend special provision 141 to read: "141 A toxin from a plant, animal or bacterial source that contains an infectious substance, or a toxin that is contained in an infectious substance, must be classed as an infectious substance in Division 6.2 and assigned to UN 2814 or UN 2900, as appropriate."

Section 173.134(a)(1) Division 6.2 (Infectious substance). Amend section 173.134(a)(1) as follows: "Division 6.2 (Infectious substance).

Section 173.134(a)(2)(ii) Biological product. Amend this section as follows: "Biological products known to contain or suspected of containing a pathogen in Risk Group 2, 3, or 4 must be classed as in Division 6.2 as infectious substance and described under UN 2814 or UN 2900, as appropriate, unless otherwise excepted."

Section 173.134(a)(4) Diagnostic specimen. Amend the text in this definition as follows: "...from a Risk Group 4 micro-organism pathogen, in which case it must be identified as an infectious substance and assigned to UN 2814 or UN 2900, as appropriate."

Section 173.134(a)(5) Regulated medical waste. Amend the definition in this section as follows: "Regulated medical waste containing an infectious substance in Risk Group 4 must be classed as in Division 6.2 as infectious substance and described under UN 2814 or UN 2900, as appropriate."

Section 173.134(b) Exceptions. The proposed text in subparagraph (b)(1) of this section addresses exceptions for biological products and states: "(1) Biological products that are known to contain or suspected of containing a pathogen in Risk Group 1, or that do not contain a pathogen." HMAC notes that the text in section 173.134(a)(6) of the NPRM, which identifies criteria for WHO Risk Groups, does not include the term "pathogen" in conjunction with Risk Group 1. Rather the WHO uses the term "micro-organism", as pathogens are not associated with Risk Group 1. As such HMAC proposes the text of 173.134(b)(1) be amended to read: "(1) Biological products that are known to contain or suspected of containing a pathogen micro-organism in Risk Group 1, or that do not contain a pathogen."

Section 173.196(a) Division 6.2 packaging. Amend the text in section 173.196(a)(2) to be consistent with similar text found in section 173.199(b)(2) and (c)(2) of the NPRM. Amended text to read: "A watertight secondary packaging. If multiple fragile primary receptacles are placed in a single secondary packaging, they must be wrapped individually or separated so as to prevent contact between them."

We again thank you for the opportunity to provide these comments and hope they are useful. Please contact us should you wish to discuss them in more detail.

Sincerely,

Michael Morrissette
Vice President